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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02253069
Other study ID # Regionskane
Secondary ID
Status Completed
Phase N/A
First received September 24, 2014
Last updated December 8, 2015
Start date September 2014
Est. completion date September 2015

Study information

Verified date December 2015
Source Region Skane
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

To study the effect of applying a PHMB-based antiseptic solution to tie-over dressings in full-thickness surgical wounds in dermatologic surgery in order to minimise the development of surgical site infections. The bacterial dynamics in wounds pre-,intra-, and postoperatively will be examined in order to understand the pathogenesis of surgical site infections better.


Description:

40 patients with suspected skin cancer in the face planned for full-thickness surgery will be randomised into two groups: One will receive a traditional tie-over dressing saturated with NaCl and the other group will receive a tie-over dressing saturated with a PHMB-based antiseptic. A quantitative and qualitative bacterial analysis of wounds by using a modified Levine's swabbing technique will be carried out pre-,intra-,and postoperatively. The effect of nasal colonisation with S.aureus on the development of surgical site infections will be investigated. All wounds will be followed a week after surgery to assess development of infections.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients planned for full-thickness skin grafting in the face

Exclusion Criteria:

- Patients with no diabetes

- Patients with no current/previous/recent antibiotic therapy

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Device:
Applying Prontosan antiseptic solution to tie-over dressings
Applying a PHMB-based antiseptic to tie-over dressings
Applying Placebo to tie-over dressings
Placebo control

Locations

Country Name City State
Sweden Department of dermatology, Skåne university hospital Lund

Sponsors (2)

Lead Sponsor Collaborator
Region Skane Vinnova

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Saleh K, Sonesson A, Persson B, Riesbeck K, Schmidtchen A. A descriptive study of bacterial load of full-thickness surgical wounds in dermatologic surgery. Dermatol Surg. 2011 Jul;37(7):1014-22. doi: 10.1111/j.1524-4725.2011.02040.x. Epub 2011 May 25. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Measuring colony forming units in swabs collected from wounds pre-,intra- and postoperatively (7 days after surgery1). Change in bacterial load will be attributed to the effect of applying an antiseptic solution to wound dressings. Wounds will be swabbed at end of surgery and then 7 days after surgery. Number and type of bacteria present will be analysed. Our hypothesis is that applying the antiseptic solution to the tie-over dressings will show a suppressed growth of bacteria when measured 7 days after surgery. 7 days No
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